Sr. Quality Engineer, Validation

Anticipated salary range:$68,500 - $97,800

Bonus eligible:No

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlex Pay
• Flexible spending accounts (FSAs)
• Short‑and‑long‑term disability coverage
• Work‑Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close:12/30/2025
* if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Engineering manages product and service quality planning, evaluation and control. This job family works cross‑functionally in the development and implementation of prevention‑based methodologies used in designing, manufacturing, testing, and correction of products and services.

The Senior Engineer Quality Engineer leads quality assurance processes at the assigned facility. This position will be responsible for developing key suppliers to improve their processes and process capability to provide enhanced raw material supply resulting in plant cost reductions through improved raw material quality, reduced waste and inventory reductions.

• Conducts & develops validation and qualification protocols, projects and studies supporting manufacturing facility start‑up and operation. Validation documentation to ensure products are manufactured in accordance with cGMP, pharmaceutical regulatory agencies, manufacturer, and Cardinal Health specifications/requirements.
• Maintains close contact with various functions to assure effective communication on challenges and opportunities related to validation.
• Provides technical support as needed.
• Develop policies, programs, SOPs, and Quality standards to meet current industry, corporate Quality, and external Regulatory requirements regarding validation.
• Supports the facility in internal and external regulatory inspections.
• Works directly with management, contract customers, and/or contract engineers.
• Maintain effectiveness of the Quality System components relevant to this position.
• Works autonomously with minimal supervision.
• Develops, maintains, and enforces Cardinal Health compliance standards.
• Learns and carries out laboratory procedures or operating equipment as needed to perform qualification testing.
• Performs other job duties as assigned.

• 2-4 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• 2 or more years of relevant work experience as a Validation Engineer, Quality Assurance Engineering, or Quality Validation Consultant working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
• Experience with equipment qualification, software validation, test method validation, and/or process validation.
• Validation and Technology Transfer process and experience with writing procedures/ reports and execution of laboratory test.
• Must be detail oriented, organized, able to multi‑task, a self‑starter, and self‑motivated.
• Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.
• Preferred:
  Experience working with radiopharmaceuticals

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning…